BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE VDD-2

    MDR report key: 2131146 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10411
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE VDD-2 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5038 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other